ID

41896

Descripción

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. The CT Organ exam form has to be filled out at the screening visit, cycle 1 and 2 observation visits and possible unscheduled visits. The CT Lymphnode Screening only has to be filled out at screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Palabras clave

Versiones (2)
  1. 9/2/21 9/2/21 -
  2. 10/2/21 10/2/21 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

10 de febrero de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Inglés

CT Imaging

1 formularios  
  1. StudyEvent: ODM
    1. CT Imaging
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Descripción

date of visit/assessment

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Descripción

subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
visit type
Descripción

visit type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
CT Organ Exam
Descripción

CT Organ Exam

Alias
UMLS CUI-1
C0178784
UMLS CUI-2
C0040405
Liver size
Descripción

Liver Size

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0456389
If enlarged, please provide size of liver
Descripción

Hepatomegaly, size

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1,1]
C0019209
UMLS CUI [1,2]
C0456389
cm
Spleen Size
Descripción

Spleen Size

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0037993
UMLS CUI [1,2]
C0456389
If enlarged, please provide size of spleen
Descripción

Splenomegaly, Size

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1,1]
C0038002
UMLS CUI [1,2]
C0456389
cm
Lymph node CT screening assessments
Descripción

Lymph node CT screening assessments

Alias
UMLS CUI-1
C0024204
UMLS CUI-2
C0040405
UMLS CUI-3
C1710477
Date of CT
Descripción

This and the following items of this group only have to be filled out at the screening visit.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040405
Lymph node number
Descripción

Please enter the six largest lymph nodes (>= 1.5 cm) to be evaluated through out the study.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0237753
Lymph node
Descripción

Lymph node

Tipo de datos

text

Alias
UMLS CUI [1]
C0024204
Lymph node location
Descripción

Lymph node location

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0450429
Longest diameter
Descripción

Lymph node, longest diameter

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C1522425
UMLS CUI [1,3]
C0024204
cm
Shortest diameter
Descripción

Lymph node, shortest diameter

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C1806781
UMLS CUI [1,3]
C0024204
cm
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Similar models

CT Imaging

1 formularios
  1. StudyEvent: ODM
    1. CT Imaging
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Screening Visit (A)
CL Item
Cycle 1 Observation (B)
CL Item
Cycle 2 Observation  (C)
CL Item
Unscheduled Visit (D)
Item Group
CT Organ Exam
C0178784 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
Item
Liver size
integer
C0023884 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Liver Size
Code List
Liver size
CL Item
normal (1)
CL Item
enlarged (2)
Hepatomegaly, size
Item
If enlarged, please provide size of liver
integer
C0019209 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Spleen Size
integer
C0037993 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Liver Size
Code List
Spleen Size
CL Item
normal (1)
CL Item
enlarged (2)
Splenomegaly, Size
Item
If enlarged, please provide size of spleen
integer
C0038002 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item Group
Lymph node CT screening assessments
C0024204 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C1710477 (UMLS CUI-3)
Date of CT
Item
Date of CT
date
C0011008 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Item
Lymph node number
integer
C0024204 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Lymph node number
Code List
Lymph node number
CL Item
one (1)
CL Item
two (2)
CL Item
three (3)
CL Item
four  (4)
CL Item
five (5)
CL Item
six (6)
Item
Lymph node
text
C0024204 (UMLS CUI [1])
Lymph node
Code List
Lymph node
CL Item
Cervical right (1)
CL Item
Femoral right (10)
CL Item
Celiac (11)
CL Item
Hilar left (12)
CL Item
Hilar right  (13)
CL Item
Iliac-common (14)
CL Item
Iliac-internal (15)
CL Item
Iliac-external (16)
CL Item
Infraclavicular left (17)
CL Item
Infraclavicular right (18)
CL Item
Mediastinal (19)
CL Item
Cervical left  (2)
CL Item
Paraortic (21)
CL Item
Parapharyngeal (22)
CL Item
Paratracheal  (23)
CL Item
Periportal (24)
CL Item
Portal (25)
CL Item
Retrocrural (26)
CL Item
Retroperitoneal (27)
CL Item
Splenic (Hepatic) Hilar (28)
CL Item
Supraclavicular right (3)
CL Item
Supraclavicular left (4)
CL Item
Axillary left (5)
CL Item
Axillary right (6)
CL Item
Inguinal left (7)
CL Item
Inguinal right (8)
CL Item
Femoral left (9)
CL Item
Other (OT)
Lymph node location
Item
Lymph node location
text
C0024204 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Lymph node, longest diameter
Item
Longest diameter
integer
C1301886 (UMLS CUI [1,1])
C1522425 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
Lymph node, shortest diameter
Item
Shortest diameter
integer
C1301886 (UMLS CUI [1,1])
C1806781 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
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